MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG OPERATING TABLE TRUSYSTEM 7000 U (DV); SURGICAL TABLE

Model Number	1723633
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported table dropped when attempting to level from trend mode.There was no report of patient injury or procedural delay.This report was filed in our complaint handling system as complaint #(b)(4).
Additional Manufacturer Narrative
Inspection of the device is pending and results will be provided by a final report.
Additional Manufacturer Narrative
Baxter performed an on-site investigation of the affected device.No malfunction or defect could be identified by the field service technician, the device was working as intended.The review of the logfiles revealed that at the day of the event the table was lowered by the user and during this movement an angle error occurred.This concluded the operating table was lowered onto a foreign equipment which then slipped away or was removed forcefully.Following this the table dropped apparently.The root cause was traced to a use error.Based on this, no further actions are required.
Event or Problem Description
Customer reported table dropped when attempting to level from trend mode.There was no report of patient injury or procedural delay.This report was filed in our complaint handling system as complaint # (b)(4).
Event or Problem Description
Customer reported table dropped when attempting to level from trend mode.There was no report of patient injury or procedural delay.This report was filed in our complaint handling system as complaint #(b)(4).
Additional Manufacturer Narrative
Baxter performed an on-site investigation of the affected device.No malfunction or defect could be identified by the field service technician, the device was working as intended.The review of the logfiles revealed that at the day of the event the table was lowered by the user and during this movement an angle error occurred.This concluded the operating table was lowered onto a foreign equipment which then slipped away or was removed forcefully.Following this the table dropped apparently.The root cause was traced to a use error.Based on this, no further actions are required.

• Brand Name: OPERATING TABLE TRUSYSTEM 7000 U (DV)
• Common Device Name: SURGICAL TABLE
• Manufacturer (Section D): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: frances coote ; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 21419845
• Report Number: 3007143268-2025-00012
• Device Sequence Number: 7913238
• Product Code: GDC
• UDI-Device Identifier: 00887761989719
• UDI-Public: 887761989719
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1723633
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 01/30/2025; 01/30/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 04/01/2025; 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown